AccessGUDID - DEVICE: EKG Patch Solution (00860007764424)

GUDID

Device Identifier (DI) Information

Brand Name: EKG Patch Solution
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EPSK001CLPA020MG
Company Name: Mg Medical Products LLC

Primary DI Number: 00860007764424
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 094834451 *Terms of Use

Device Description: Portable, 12-lead ECG testing kit.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
11413	Electrocardiograph, professional, single-channel	A device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from only one configuration of electrodes (ECG-leads) at a time (single-channel). It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or data telemetry features might also be included.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OEZ	Cardiovascular Procedure Kit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Atmospheric Pressure: between 500 and 1060 millibar
Handling Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 27 Degrees Celsius
Special Storage Condition, Specify: Keep away from sunlight.
Special Storage Condition, Specify: Keep dry.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1b7cc7a5-871a-4f7b-a095-966584cf6e80
Public Version Date: January 17, 2025
Public Version Number: 1
DI Record Publish Date: January 09, 2025